HHS Finalizes Good Guidance Practices Rule and Issues Advisory Opinion Regarding Compliance with Notice-and-Comment Obligations

Today, the Department of Health and Human Services (HHS) finalized a Good Guidance Practices rule to help ensure that the public receives appropriate notice of new guidance documents and that HHS guidance documents do not impose obligations on regulated parties that are not already reflected in statutes or regulations. This final rule implements Executive Order 13891 and is part of a broader regulatory reform initiative within HHS.

The Good Guidance Practices regulation clarifies HHS’s obligations under the Administrative Procedure Act and enhances how HHS issues and maintains guidance documents. The rule requires all guidance documents issued after the rule’s effective date to self-identify as “guidance,” carry a disclaimer indicating that the contents of the document generally cannot impose binding new obligations that exceed requirements set forth in statutes or regulations, and include certain information designed to ensure transparency and uniformity across guidance documents, including citations to any statutory and/or regulatory provisions that the guidance document is interpreting or applying. Guidance documents that qualify as “significant guidance documents” can only be issued after a public notice-and-comment period. HHS must include all of its guidance documents in a single, searchable guidance repository, which is located at HHS.gov/Guidance.  Any historical guidance document not posted to the guidance repository by the effective date of the rule will be considered rescinded.  

“For too long, federal agencies have succumbed to the temptation to create law without notice and comment or public participation,” said HHS Chief of Staff Brian Harrison. “Our Good Guidance Practices regulation empowers and protects those we regulate by requiring increased transparency and raising the standards for issuing significant guidance.” 

The Good Guidance Practices regulation additionally creates a petition process, which gives interested parties an opportunity to petition HHS to correct unlawful guidance. Today, HHS also announced the withdrawal of a guidance document that was identified, in response to a Request for Information, as unlawfully purporting to impose binding obligations. As the announcement, available here, explains, HHS encourages interested parties in the future to bring similar matters to the Department’s attention by utilizing the petition process. More information about how to submit a petition is available on HHS.gov/Guidance.

The withdrawn guidance document was also inconsistent with the Supreme Court’s decision last year in Azar v. Allina Health Services, 139 S. Ct. 1804 (2019). The HHS Office of the General Counsel (OGC) today released an advisory opinion providing guidance around the steps HHS is taking to comply with this Supreme Court decision. In Allina, the Supreme Court determined that HHS must use notice-and-comment rulemaking in certain circumstances, even where the Administrative Procedure Act does not require such rulemaking. The OGC Allina advisory opinion, available here, clarifies what the public can expect HHS to do in order to satisfy Allina’s requirements regarding notice-and-comment rulemaking.

To view the final rule, please visit https://www.hhs.gov/sites/default/files/hhs-eo-13891-final-rule.pdf

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